(23 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
POWDER-FREE POLY VINYL EXAM GLOVES, COLOR: WHITE
The document describes the acceptance criteria and the study for "POWDER-FREE POLY VINYL EXAM GLOVES, COLOR: WHITE."
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| ISO 2859 | Met or exceeded |
| Bio Burden | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specific tests (ASTM D 5250-00, D 5151-00, D 6124-00, ISO 2859, Bio Burden, Dermal Sensitization, Primary Skin Irritation). The data provenance is implied to be from tests performed on the device by Heyuan Hongli Industries, Inc., which is based in China. The submission date is July 11, 2002, suggesting these were retrospective tests conducted on the manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are standardized and do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI device would. Instead, these are material and biological safety tests with predefined methodologies and pass/fail criteria.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are standardized and have objective pass/fail criteria. There isn't an adjudication process involving multiple human reviewers to determine a "ground truth" for these types of tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This device is a medical glove, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical product (medical glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and assessments based on the specified ASTM and ISO standards, as well as bio-compatibility tests. These standards define the acceptable physical properties (e.g., strength, dimensions), absence of holes, and biological safety (e.g., absence of skin irritation, allowable bioburden). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device's testing.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product and does not involve a training set as a machine learning model would. Production quality control would involve sampling from manufacturing batches, but this is distinct from "training data."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for a medical glove in the context of AI/algorithm development.
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AUG 0 8 2002
510(k) SUMMARY
| Submitted For: | HEYUAN HONGLI INDUSTRIES, INC.No. 2, Mingzhu IndustrialHeyuan, Guang DongChina |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for Hycare International Co., Ltd.JANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone: 775-342-2612Fax: 775-342-2613E-Mail: Tuckerjan@aol.com |
| Date of Submission: | 11 July 2002 |
| Device Name: | POWDER-FREE POLY VINYL EXAMGLOVES, COLOR: WHITEClass I Device, 80LYZ |
| Proprietary Name: | (Multiple Labels_Powder-Free Poly-Vinyl Exam GlovesColor: White |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. Except for Color, itis substantially Equivalent to the devices manufacturedby Shanghai Poseidon Plastic Products Company Limited(K992979) and Glormed International (K002340) |
EXHIBIT L
A... 48 & 49
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510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 5250-00 ASTM D 5151-00 ASTM D 6124-00
ISO 2859
Bio Burden
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
Except for color, this device is substantially equivalent to the devices approved as K992979 and K002340.
EXHIBIT L
Page 49 of 49
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DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 0 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heyuan Hongli Industries, Inc. C/O Ms. Janna P. Tucker Official Correspondent for Heyuan Hongli Industries, Inc. Tucker and Associates 198 Avenue De La D' emerald Sparks. Nevada 89434-9550
Re: K022305
Trade/Device Name: Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves. Color White Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: July 11, 2002 Received: July 16, 2002
Dear Ms. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Tucker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
HEYUAN HONGLI INDUSTRIES, INC. APPLICANT:
510(k) NUMBER:
POWDER-FREE POLY-VINYL DEVICE NAME: EXAMINATION GLOVES, COLOR: WHITE
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Clim S. Lim
(Optional Format 1-2-96)
esthesiology, General Hospital,
510(k) Number. K022305
EXHIBIT B
Page 2 of 49
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.